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A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: May 20, 2009
Last updated: May 8, 2012
Last verified: May 2012
This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.

Condition Intervention Phase
Solid Cancers Drug: MEGF0444A Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 of cycle 1 ]
  • Incidence, nature, relatedness, and severity of adverse events [ Time Frame: Day 1 to study completion ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution [ Time Frame: Following administration of study drug ]

Enrollment: 30
Study Start Date: May 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MEGF0444A
Intravenous escalating dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit

Exclusion Criteria:

  • Inadequate hematologic and organ function
  • Anti-cancer therapy within 4 weeks prior to initiation of study treatment
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
  • Active infection or autoimmune disease
  • Pregnancy (positive pregnancy test) or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00909740

Sponsors and Collaborators
Genentech, Inc.
Study Director: Louie Naumovski, M.D., Ph.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT00909740     History of Changes
Other Study ID Numbers: MEF4693g
Study First Received: May 20, 2009
Last Updated: May 8, 2012

Keywords provided by Genentech, Inc.:
Solid Tumor
Cancer processed this record on August 16, 2017